Which IRB Regulations do I follow?

The Office of Human Research Protections first publishsed the revised regulations in January 2018 with a compliance date of January 19, 2019.

If you submitted an IRB after January 19, you are already following the 2018 Requirements.

But what about the older studies, you ask?  Appalachian plans to transition all active, non-exempt studies to the "new regs" (called the 2018 Requirements) in the next 12 months. 

If you have an approved IRB that was submitted for review before January 16, 2019, your study was reviewed using the "old regs" (the Pre 2018 Requirements). You do not have to do anything differently, for now.  However, you will have to renew your study in 2019 (IRBIS lets you know with an Expiration warning).  When you renew--AND YOU MUST RENEW YOUR STUDY--we will review it under the 2018 Requirements.  If your study was Expedited, our review will likely result in the removal of a Continuing Review requirement, or your study may be changed to Exempt.  TRANSLATION:  No more renewals under the 2018 Requirements!  (If your study was a Full Board review, sorry--renewals don't go away.)

If you aren't up for renewal any time soon, but you need to modify your study, this is business as usual.  We will review your study under the Pre 2018 Requirements.  We aren't transitioning anyone until renewals.

You will notice that IRBIS has added a lot more questions when you open your current studies.  These will need to be answered to comply with the 2018 Requirements.  You don't have to do this until you renew, unless you really, really want to.

Published: Jan 30, 2019 5:29pm

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